Male urinary collection system and external catheter therefor

ABSTRACT

An external catheter, and the methods of making and using such a catheter, for a male urinary incontinence collection system, such system also including an adhesive attachment for holding the catheter in place. The catheter takes the form of a tubular sheath of thin elastic material having a cylindrical body section, a tapered neck section extending from the body section, and a reduced drainage tube section projecting from the neck section. Within the sheath, and constituting a unitary part thereof, is a tubular inner sleeve of soft elastic material having a distal end portion disposed within the neck section and a proximal end portion merging with the sheath&#39;s cylindrical body section. The sleeve tapers distally to define an annular space thereabout, and terminates in a reduced distal opening located at an intermediate point within the neck section. The sheath may be produced by a dipping process that includes the preliminary step of stretching a pre-formed tubular member (which ultimately forms the inner sleeve) over a dipping form, followed by successive dipping steps.

RELATED APPLICATIONS

This application is a continuation of co-pending application 613,279,filed May 24, 1984, now U.S. Pat. No. 4,581,026, which was acontinuation-in-part of application 521,224, filed Aug. 9, 1983(abandoned), which in turn was a continuation of application 271,086,filed June 5, 1981 (abandoned).

BACKGROUND AND SUMMARY

In co-pending co-owned patent 4,378,018, there is disclosed a maleurinary drainage device composed of a thin resilient external catheterand an underlying adhesive sealant pad for holding the catheter in placeand for producing an effective seal to prevent urine backup and leakage.The pad is formed of compressible, deformable, water-resistant, andelastic sealant material and includes a ring portion adapted to sealabout the penis at or directly behind the glans thereof and a pair ofintegral strap portions projecting from the ring portion and intended toextend inwardly (proximally) along the penile shaft. The strap portionsfunction primarily to provide catheter retention, whereas the ringportion coacts with the retained catheter and with the penis to serveprimarily as a barrier against fluid backup.

The external catheter of U.S. Pat. No. 4,378,018 is provided withconvolutions of graduated size in the neck region between the catheter'scylindrical body portion and its reduced drainage tube portion. Suchconvolutions permit axial as well as radial expansion and contractionand thereby absorb tensioning forces that might otherwise occlude thelumen or reduce effectiveness of the seal between the pad and catheter,or pad and penis, or both. In addition, the convolutions increase theinternal capacity of the neck region to accommodate sudden discharges ofurine, thereby reducing the possibilities of fluid backup, ordisengagement of or damage to the drainage device, under suchcircumstances.

Conditions may nevertheless arise where a surge of fluid may create aback pressure that may weaken the adhesive seal between the pad andcatheter, or between the pad and the penis, resulting in leakage. Shouldthe neck portion of the catheter become enlarged or distorted because offluid pressure, the forces generated by such pressure will tend to urgethe inner surfaces of the catheter laterally out of sealing contact withthe annular portion of the pad. Furthermore, apart from the possibilityof leakage arising because of surges of fluid causing a failure of theadhesive seal, there is always the risk that gradual deterioration ofthat seal will occur because of exposure to the urine over an extendedperiod, or that the material of the pad will tend to deteriorate becauseof continuous exposure to fluid, resulting in undesirable back flow andleakage.

U.S. Pat. No. 2,940,450 discloses a drainage device in the form of anexternal catheter connected to a flexible tube leading to a suitablereceptacle, the catheter being held in place by drawstrings which may betied together to produce a secure fit. In U.S. Pat. No. 3,835,857,elastic adhesive tape is wrapped about the catheter in place ofdrawstrings, and in U.S. Pat. No. 3,863,638 a liner is disposed betweenthe catheter to reduce leakage and promote patient comfort. U.S. Pat.No. 4,187,851 discloses a method of forming such a liner in place bywrapping the penile shaft with a double-faced adhesive strip prior toapplication of the elastic external catheter.

Those devices that have the advantage of being easily and quicklyapplied tend to be less effective in terms of retention and preventionof fluid backup, whereas those that are more satisfactory in the latterrespects are often relatively difficult to apply and more likely tocause patient discomfort and urethral constriction. Ease of applicationand removal are particularly important because an incontinent patientmay have other disabilities that make complicated manipulationsdifficult if not impossible to perform. Other patents reflecting thestate of the art are 364,932, 3,721,243, 3,361,857, 3,511,241,2,891,546, 4,022,213, 3,526,227, 3,353,538, 1,423,537, 1,015,905,3,604,424, 4,239,044, 1,490,793, 3,559,651, and 3,405,714.

One aspect of this invention lies in the recognition of the problem ofmaintaining effective adhesive seals under the conditions describedabove; a second aspect lies in recognizing that the degradation orrupture of such seals may be prevented by providing the externalcatheter with an elastic tapered internal sleeve disposed within theneck portion of the outer sheath. In use of the catheter, the sleeve isstretched into sealing engagement with the glans to provide a barrierthat tends to prevent liquid from migrating rearwardly or proximallytowards the adhesive attachment between the cylindrical portion of thecatheter and the penis. Should a surge urine within the neck portion ofthe catheter cause back pressure, such pressure only tends to increasethe effectiveness of the liquid barrier formed between the glans and thesleeve stretched thereabout. Furthermore, when an annular portion of thesleeve is in direct contact with the adhesive pad, as where the sleeveextends slightly behind (proximal to) the corona of the glans, such backpressure increases rather than diminishes the force of adhesive contactwith the wearer and thereby promotes an even more effective adhesiveseal.

In a preferred embodiment, the adhesive attaching means takes the formof a pressure sensitive adhesive coating along the inner surface of thesheath's cylindrical portion directly behind the sheath's tapered necksection. In some cases the adhesive coating may also be applied to anarrow annular band at the proximal extreme of the sleeve; however, inthat event the band should be narrow enough that adhesive contact withthe wearer is still limited to an area behind (proximal to) the coronaof the glans. Instead of an adhesive coating, the adhesive means mayalternatively take the form of a resilient skin-protecting adhesive padof the type disclosed in aforementioned U.S. Pat. No. 4,378,018,particularly as shown in FIGS. 8-13 thereof. In either case, theadhesive means serves the important function of holding the sheath inposition with its stretched inner sleeve retained in protectivenon-adhesive sealing engagement with the glans. The sleeve includes aproximal end portion, merging and permanently interated with thecylindrical body section of the sheath, and an elongated distal endportion extending and tapering distally into the sheath's neck section.The elongated distal end portion of the sleeve terminates in a reducedopening spaced axially from the distal end of the neck section and hasan outer surface unsecured and normally spaced from the neck sectionalong the full length and circumferential extent of the sleeve's distalend portion to provide an expansion space between the sleeve and theneck section. Any increase in pressure within the annular space aboutthe sleeve only tends to urge the sleeve into tighter sealing engagementwith the glans. The result is an external catheter which has theadvantages of adhesive attachment in terms of patient comfort andconvenience, in contrast to prior devices requiring belts, harnesses,and the like, and which at the same time provides a high degree ofsecurity against fluid backup and leakage, protects the sensitive dermalsurfaces of the glans against direct exposure to urine and theexcoriating effects that prolonged fluid contact might otherwiseproduce, and maintains an effective fluid-tight seal without thediscomforts of direct adhesive contact with the glans.

The catheter may be formed in a dipping process that includes thepreliminary step of stretching a pre-formed tubular member, ultimatelyto become the inner sleeve, over a dipping form. In its unstretched oruntensioned state, the tubular member has a distal end portion thattapers and terminates in a reduced distal opening. After stretching thetubular member upon the form, the distal end portion of that member istreated to prevent liquid latex from bonding thereto. Thereafter, theform is dipped into a latex bath and the latex coating is then cured toproduce the outer sheath, or at least that portion of the outer sheathsurrounding the inner sleeve. When the catheter is stripped from theform, the sleeve returns to its original untensioned state, therebycreating an annular space between the outer distal portion of the sleeveand the inner surface of the sheath's neck section.

Other features, objects, and advantages of the invention will becomeapparent from the drawings and specification.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a side elevational view, shown partly in section, of anexternal catheter embodying the present invention, the sheath of thecatheter being depicted in unfolded or unrolled condition.

FIG. 2 is a view similar to FIG. 1 but showing the sheath in rolledcondition as it would appear prior to application.

FIGS. 3 and 4 illustrate the steps of placing the catheter over a penisupon which an adhesive and protective sealing pad has been fitted.

FIG. 5 is an enlarged fragmentary generalized sectional view of acatheter showing the relationship between the inner sleeve and sheath.

FIG. 6 is a fragmentary sectional view illustrating the relationshipbetween sheath and sleeve in one embodiment of the catheter, and FIGS.7-11 illustrates the sequence of steps for forming a catheter havingsuch a relationship of elements.

FIG. 12 is a fragmentary sectional view depicting a second embodiment,and FIGS. 13-17 show the method steps for forming a catheter having therelationship of elements represented by the second embodiment.

FIG. 18 is an elevational view shown partly in section of a thirdembodiment.

FIG. 19 illustrates the step of placing the catheter of the thirdembodiment upon the penis.

FIG. 20 is a fragmentary sectional view showing the sheath of the thirdembodiment fitted upon by the penis and also showing the protectiveeffect of the inner sleeve in shielding the glans against liquidcontact.

FIG. 21 is a sectional view similar to FIG. 20 but showing, in somewhatexaggerated form for illustrative purposes, the sheath of the thirdembodiment as a surge of urine suddenly expands the sheath's stretchableneck section.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring to the drawings, the numeral 10 generally designates anexternal catheter formed of soft, highly elastic, natural or syntheticrubber. Natural latex is preferred but other elastomers having similarproperties may be used. The catheter includes an elongated outer sheath11 and an inner sleeve 12, the two being integrated or permanentlyjoined in the manner hereinafter described.

Referring to FIG. 1, the sheath 11 includes an elongated cylindricalsection 13, a reduced drainage tube section 14, and a tapered necksection is disposed therebetween. The wall thickness of the cylindricalsection 13 is substantially less than that of the neck and drainage tubesections. For example, the cylindrical section may have a wall thicknesswithin the general range of 0.006 to 0.010 inches and, in general, istoo thin or limp to retain a cylindrical configuration without support.In contrast, the wall thicknesses of the drainage tube and neck sectionsmay be 0.050 inches or more and are generally great enough so that suchsections will retain the configurations shown in the absence ofdistorting forces and will spring back into the illustrated shapes whendistorting forces are removed.

At its forward or distal end, neck section 15 is provided with a roundedtaper leading to a reduced opening 16. The drainage tube section 14 thatmerges with the tapered neck section 15 is provided with a plurality ofconvolutions or annular enlargements 17 and 18. Two such convolutions ofgraduated size are depicted, their purpose being to permit greaterstretchability, bending, and twisting of the drainage tube section whenthe device is in use, and to do so with less chance that kinking orobstruction of the lumen might occur. Also, since the interior of thedrainage tube section is enlarged at such convolutions, the convolutionsincrease the fluid capacity of that section and provide a reservoir foraccommodating surges of fluid when the device is in use.

The inner sleeve 12 has a distal end portion 12a disposed within theneck section of the sheath and a proximal end portion 12b within thesheath's cylindrical body section. The relationship is depicted mostclearly in the generalized and enlarged view of FIG. 5 where it will beseen that the proximal end portion has about the same cross sectionaldimensions as the cylindrical body section and merges smoothly with thatsection, while the distal portion 12a tapers forwardly and inwardly,terminating in a reduced distal opening 19. Opening 19 is spaced wellbehind (i.e., proximal to) opening 16 at the distal end of neck section15. The setback also results in the provision of an annular space 20between the outer surface of the sleeve's distal end portion 12a and theinner surface of neck section 15. The wall thickness of the sleeve 12may be varied but, to insure conformability, good sealing properties,and wearer comfort, such thickness should approximate that of therelatively thin cylindrical body section 13 of the sheath. Thus, boththe cylindrical body section 13 and the inner sleeve 12 should appear asthin, limp, highly stretchable membranes, in contrast to the drainagetube and neck sections 14, 15 with their shape-retaining properties.

In FIGS. 1 and 5 the sheath 11 and inner sleeve 12 are shown as mergingsmoothly with one another. Although the sheath and sleeve are indeedpermanently integrated, and are formed of essentially the same material,they may be formed separately to facilitate production and to achievethe desired setback of the sleeve within the neck section of the sheath.FIG. 6 illustrates a construction wherein the sleeve 12 is actually acontinuation of the cylindrical body section of the sheath. The necksection 15 is permanently joined to the body section 13 at 22. Such aconstruction may be made in accordance with the steps depicted in FIGS.7-11.

FIG. 7 shows a dipping form 23 having a support shaft 24 that may bemounted upon any suitable reciprocable mechanism (not shown) for dippingthe form into a suitable bath of liquid latex. Prior to any dippingoperations, an open-ended latex tubular member 25 is stretched upon thecylindrical portion of the form (FIG. 8). Such a fitting and stretchingoperation may be most readily performed starting with the tubular member25 in fully rolled condition. The rolled annulus is then simply slippedupwardly onto the lower end of the form 23, is advanced until thereduced opening 19 at the member's lower end is stretched to receive thelower end of the cylindrical portion of the form, and the annulus isthen unrolled. Except for the provision of opening 19 at its lower end,tubular member 25 is generally similar to a conventional latex condom.

While some stretching of the upper portion of member 25 necessarilyoccurs as that member is fitted upon form 23, the greater stretchingoccurs at the lower portion of that member because in its relaxed statesuch lower portion is provided with a rounded taper leading to opening19 (FIG. 7). It is the stretched lower portion of the tubular memberthat will ultimately become the elongated distal portion 12a of thesleeve of the finished catheter (FIG. 8). The upper portion, subjectedto only minimal stretching, is to become the cylindrical section 13 ofthe sheath.

The form 23 with the elastic tubular member stretched thereon is thensubjected to successive dipping steps to produce the neck section anddrainage tube section of the final catheter. FIG. 9 indicates that theform is first dipped to a level x--x in a solution or suspension of asuitable release agent that will prevent latex solution from adhering tothe treated surface. An alcohol suspension of diatomaceous earthmarketed under the designation Snow Floss by Johns-MansvilleCorporation, New York, N.Y., has been found particularly effective, butother release agents having similar properties may be used. Thereafter,the form is dipped into an aqueous slurry of calcium nitrate or othersuitable activator capable of causina thickening of the latex layer tobe subsequently formed by a dipping process, all as well known in theart, and diatomaceous earth. It will be observed that the level y--y towhich the form is dipped into the activator slurry is spaced below thelevel x--x of the release agent treatment (FIG. 10).

After removal of the form from the activator slurry, the coating isallowed to air dry for a short interval (1 to 3 minutes), and the formis then lowered slowly into a latex bath to a level z--z spaced abovex--x as indicated in FIG. 11. The form should remain within the bath foran interval within the range of about 4 to 5 minutes; thereafter, theform is removed, dipped in and out of a coagulant solution of calciumnitrate in alcohol. One or more additional dippings into the latexsolution, followed by exposure to coagulant, may be undertaken todevelop the desired wall thickness. Thereafter, the form or mandrel withthe dip coating thereon is placed in an oven at approximately 135° F.for 40 minutes to cure the latex. The form and nearly completed catheterretained thereon are introduced into a water bath maintained atapproximately 160° F. for an interval of 30 minutes or more to leachimpurities therefrom. Following the leaching step, the catheter isstripped from the form or mandrel, treated with talc to prevent thelatex from sticking to itself, and dried. The catheter is completed bycutting away the tip to form the opening at the distal end of thedrainage tube section. The end result is a catheter as generallydepicted in FIGS. 1 and 5 but in which the layers are formed or joinedin the manner specifically illustrated in FIG. 6.

Effective bonding between the two layers of latex may be enhanced by theuse of solvents or adhesives applied to the annular zone of the tubularmember 25 between lines x--x and y--y. It has been found, however, thatan effective bond sufficient to permanently integrate the two layers maybe simply achieved by dipping the tubular member into a bath of thecoagulant described above following the step of fitting the member 25upon mandrel 23 (FIG. 8) and before the step of dipping the form intothe release agent (FIG. 9). The coagulant coating should be air driedfor a short interval (approximately one minute) prior to the dippingstep of FIG. 9.

The external catheter of FIGS. 1 and 5 may also be made in accordancewith the method steps depicted in FIGS. 13-17 to produce a constructionhaving the particular arrangement of layers shown in FIG. 12. In thatembodiment, the inner sleeve 12 is formed from the pre-formed tubularmember 125 stretched upon the form or mandrel 23, and the cylindricalsection 13, neck section 15, and drainage tube section 14 are thenformed by a dipping process and are thus integrated with the tubularsleeve. The procedural steps are similar to those described inconnection with FIGS. 7-11 except that the tubular member 125 isrelatively short and the cylindrical section 13 of the sheath is formedduring the dipping process rather than being provided as an extension ofthe pre-formed tubular member.

Specifically, the open-ended latex tubular member 125, having a taperedlower end with a reduced opening 19, is stretched over form 23 into theposition depicted in FIG. 14. The form is dipped into a coagulant bathand, following an air-drying interval of approximately one minute, isthen dipped into a solution or suspension of the release coatingmaterial to a level x--x represented in FIG. 15. The form is then dippedinto the activator bath of calcium nitrate solution to level y--y (FIG.16) and, after an air-drying period of approximately 2 minutes, issuccessively dipped into latex and coagulant baths. The latex-dippingsteps are essentially the same as previously described except that theform is lowered into the latex and coagulant baths to a level w--w nearthe upper end of the cylindrical body of the form or mandrel 23 (FIG.17). The leaching, stripping, and trimming steps are the same aspreviously described.

It is to be noted that in both methods the tapered portion of thetubular member 25 or 125 is pre-formed and stretched upon the mandrel.In both instances, when the dipping processes are completed and thecatheters are stripped from the mandrels, the stretched inner sleeves 12are free to contract and thereby produce the setback depicted in FIGS.1, 5, 6, and 12. Specifically, the released distal portions of thesleeves retract axially and proximally to produce the axial spacingbetween sleeve opening 19 and sheath opening 16, and also retractinwardly to form the annular spacing 20 (FIG. 5).

The catheter would be rolled prior to use, and would normally bemarketed in the rolled condition depicted in FIG. 2. It will be observedthat the annular roll 27 is of double thickness, being formed of boththe cylindrical body section 13 of the sheath and also a substantiallength of sleeve portion 12. The reduced opening 19 at the distal end ofthe sleeve, as well as the material of the sleeve immediatelysurrounding that opening, are therefore fully exposed at the mouth ofthe rolled catheter.

In use of the external catheter, a patient first applies an adhesive pad30 to the penis 31 as generally illustrated in FIG. 3. The particularpad shown in the drawings is the pad disclosed in the aforementionedU.S. Pat. No. 4,378,018; however, it is to be understood that while sucha pad is particularly suitable, other types of adhesive pads may beused. The pad might, for example, be a spiral wrapping of adhesivematerial as disclosed in U.S. Pat. No. 4,187,851 and in other prior art.The particular pad shown in FIG. 3 is preferred because the ring portion30a disposed behind the corona 32 of glans 33 provides a smooth annularsurface for sealing contact with the catheter, thereby preventing fluidbackup and leakage, while the rearwardly (proximally) extending strapportions 30b act primarily as retaining elements for adhesively holdingthe sheath in place, thereby preventing disruption of the fluid-tightseal in the annular zone behind the corona and particularly thenon-adhesive fluid-tight seal formed by the sleeve 12 stretched aboutthe glans. The pad may be formed of any suitable resilient materialwhich is not only deformable but also compressible and at least somewhatelastically recoverable. To obtain these properties, the sealant pad maybe prepared from a composition composed principally of an elastomericmaterial such as synthetic or natural rubber. One such material isdescribed in U.S. Pat. No. 2,570,182, being composed of a blend of nitrorubber and polyvinyl chloride. A material of this kind has been soldunder the name "Ensolite", by Uniroyal, Inc. Its use in a sheetarrangement for a male urinary drainage device is described in U.S. Pat.No. 4,187,851. Another such material is composed principally ofpolyacrylamide and glycerine. This material has been used in ostomyrings and blankets, and has been sold under the name "Crixiline" byDanal Laboratories, Inc., St. Louis, Mo. Other suitable materials can beformulated from gelled mixtures of hydrocolloids such as karaya orcarboxymethyl cellulose and polyhydroxy alcohols such as glycerin orpropylene glycol, which preferably includes a few percent of fumedsilica, as described in co-pending application Ser. No. 383,523, filedJune 1, 1982 for "Protective Sealing Composition in Molded Form forApplication to the Skin," and prior related applications identifiedtherein, all having a common assignee with the present application.Also, to further improve the desired properties of such compositions foruse in the present invention, a minor proportion of polyacrylamide resincan be incorporated, and cross-linked by gamma irradiation. See U.S.Pat. Nos. 4,115,339 and 4,258,715.

The catheter is unrolled over the penis in the manner shown in FIGS. 3and 4. Specifically, the rolled catheter is positioned with the exposedapertured portion of sleeve 12 in contact with glans 33, and thecatheter is then unrolled to allow the sleeve to retract into snugcontact with the glans.

Since the distal portion 12a of the sleeve is under slight tension whenthe external catheter is properly fitted upon the wearer, most of thesurface area of the glans, and the areas of the penile shaft and theadhesive pad 30 proximal to the glans, are protected by the sleeveagainst direct liquid contact. Should there be a surge in the dischargeof urine, an uncontrollable occurrence not infrequently associated withspinal injuries, substantial space is provided within the neck section15 and the convoluted portion of the drainage tube section to aommodatethat surge. Ballooning of the sheath and the development of backpressure may nevertheless occur, as indicated in broken lines in FIG. 4.However, should such back pressure develop, such pressure would have theeffect of urging the distal end portion 12a of the sleeve into eventighter contact with glans 33, thereby reducing the possibility ofleakage. Furthermore, any such back pressure applied to the sleeve 12 inthe vicinity of adhesive pad 30 will tend to increase the force ofcontact between the sleeve and pad and further reduce the possibility ofleakage. The result is that the external catheter 10, when used incombination with a suitable adhesive sealing pad, is highly effective inavoiding problems of leakage should sudden surges of fluid, accompaniedby the development of back pressure, take place.

It is believed apparent that the external catheter also operates toprotect the adhesive seals between pad 30, catheter 10, and penis 31against exposure to liquid under normal conditions of use, therebyresulting in a combination which should be expected to give the wearergreater security against leakage for longer wearing intervals.Minimizing deterioration of the pad and its sealing properties, as wellas the greater comfort arising from reduced continuous exposure of theglans and shaft to the back flow of urine, are significant advantages ofthis construction.

A suitable composition for use in preparing the sealant pads 30comprises a mixture of hydrocolloid, polyhydroxy alcohol, fumed silica,and polyacrylamide. A general formula for this type of composition isset out below.

    ______________________________________                                        General Formula                                                               Ingredients      Parts by Weight                                              ______________________________________                                        Hydrocolloid     15-25                                                        Polyhydroxy alcohol                                                                            50-70                                                        Fumed silica     1-3                                                          Polyacrylamide resin                                                                            5-20                                                        ______________________________________                                    

In the above formula, the hydrocolloid may be karaya gum or othernatural hydrocolloid such as gelatin, pectin, etc., or a synthetic gumsuch as carboxymethyl cellulose or hydroxyethyl cellulose, or mixturesthereof. The polyhydroxy alcohol is preferably glycerin, or mixtures ofglycerin and propylene glycol, but other polyhydroxy alcohols can beused. An example of suitable fumed silicas are the Cab-O-Sil products ofCabot Corporation, Boston, Mass. The polyacrylamide resin may be a"Reten" resin of Hercules, Incorporated, as described in U.S. Pat. Nos.4,115,339 and 4,258,271. The cited patents also describe gammairradiation cross-linking of the polyacrylamide resins, which is adesirable procedure in preparing the material for the sealant pads ofthe present invention. An example of a presently preferred specificformulation is as follows:

    ______________________________________                                        Specific Formula                                                              Ingredients             Weight %                                              ______________________________________                                        Karaya powder           15.00                                                 Sodium carboxyethyl cellulose                                                                         5.00                                                  Polyacrylamide (non-ionic)                                                                            10.00                                                 Polyvinyl alcohol       5.00                                                  Fumed silica            2.00                                                  Glycerin                59.73                                                 Propylene glycol        3.05                                                  Methyparaben            0.09                                                  Propylparaben           0.02                                                  Butylparaben            0.11                                                                          100.00%                                               ______________________________________                                    

In compounding the foregoing ingredients, a mixture can first beprepared of the liquid ingredients (glycerin, propylene glycol, and theparabens). Fumed silica is then dispersed in the liquid mixture, andthereafter the other powder ingredients are added (karaya, carboxymethylcellulose, polyacrylamide, and polyvinyl alcohol). The completed mixtureis then molded to form the pads, or formed into sheets for use inpreparing the pads. Either in pad or sheet form, the material ispreferably subjected to gamma irradiation, preferably from a Cobalt-60radiation source. The amount of radiation employed should be sufficientto sterilize the material, and to achieve cross-linking of thepolyacrylamide resin. For example, a radiation level of 2.5 megarads issatisfactory. To increase tackiness, the final product is then coatedwith a conventional medical-grade vinyl acrylic pressure sensitiveadhesive.

FIGS. 18-21 illustrate an embodiment of the invention which differs fromthe arrangement of FIGS. 1-5 primarily because the adhesive attachmentmeans takes the form of an adhesive inner coating or layer 50 within thecylindrical section 13' of sheath 11' rather than as a separate adhesivepad 30. The adhesive coating 50 extends proximally from the proximal endof sleeve 12' and is intended to secure the cylindrical section 13' tothe shaft of the penis directly behind corona 32. In the illustrationgiven, the coating extends a major portion of the axial length ofcylindrical section 11'; however, the coating may have an axialdimension greater or less than that shown. The primary function of theadhesive coating is to secure the cylindrical section 13' to the shaftof the penis behind corona 32 of glans 33 as shown in FIG. 20, therebyfunctioning as retaining means to maintain the stretched sleeve 12' ofthe device in protective non-adhesive sealing engagement with glans 33.Because the sleeve is in stretched condition, the sleeve exerts a forcetending to urge the entire sheath in a distal direction, and that forceis increased when a surge of urine expands the neck section 15 and tendsto displace that neck section distally. Such forces are resisted by theadhesive means 50, thereby maintaining the stretched sleeve 12' incontact with the glans. It is important that such retention is achievedwithout tenacious (and possibly injurious) adhesive contact with thesensitive dermal surfaces of the glans.

In use, the drainage tube section 14' would be connected to a suitabledrainage tube (not shown) as previously described. Upon urination, fluidflows from the neck section and drainage tube section to a suitablecollector. However, a small residual amount of urine frequently remainswithin the neck section 15' as represented by numeral 51 in FIG. 20. Inthe absence of sleeve 12', such residual urine would remain in contactwith the glans and could have an injurious excoriating effect on thedelicate tissues of the glans near the corona.

Therefore, unlike other external catheters, the catheters of thisinvention are provided with an inner sleeve 12, 12' that in normal useis stretched about the glans 33, or at least the proximal portion of theglans near the corona, to protect the glans and at the same time preventleakage of fluid in a proximal direction beyond the sleeve. The adhesivemeans 30, 50 holds the stretched sleeve in operative condition and alsoprovides a secondary seal to prevent fluid backup. Should a surge ofurine cause ballooning of the neck section 15, 15', as indicated in FIG.4 (broken lines) and FIG. 21, the effect is to force the stretchedsleeve into even tighter sealing contact with the glans 33.

The adhesive coating or band 50 may be any suitable medical-gradepressure sensitive adhesive of the type commonly used for medical tapesand other products. An acrylate ester copolymer adhesive as commonlyused for adhesive bandages is effective, and other adhesives havingsimilar properties are also well known and may be used. Ideally, theproduct is supplied to the user in rolled form as depicted in FIG. 19,thereby simplifying application of the sheath and helping to insure thatthe adhesive coating 50 will be directed into contact only with the lesssensitive skin along the shaft of the penis behind the corona of theglans. To prevent the pressure sensitive adhesive from sticking to theouter surface of the sheath when it is to be unrolled, the outer surfacemay be coated with any suitable elastomeric release agent to which theadhesive has less affinity. A silicone rubber coating along the outersurface of the sheath is effective for that purpose, but other coatingmaterials capable of producing similar results, as well known in theadhesive tape industry (where such tapes are commonly supplied in rolledform and where the adhesive must release from the outer surface of thetape as it is unrolled) may be used. Alternatively, an interliner of thetype also commonly used in the tape industry may be interposed betweenthe adhesive coating 50 and the outer surface of the sheath, suchreleasable interliner being stripped away by the user to expose theadhesive as the sheath is unrolled.

Assuming that the external catheter is supplied to the user in rolledform, the catheter is first positioned as shown in FIG. 19 with theglans of the penis inserted slightly into the opening 19' of sleeve 12'.As the sheath is unrolled, the stretched sleeve 12' is drawn over themajor area of the glans directly behind the urethral meatus 52. Finally,the adhesive-coated cylindrical section 13' of the sheath is broughtinto contact with the shaft of the penis behind corona 32, therebyimmobilizing the catheter and maintaining the stretched sleeve 12' insealing but non-adhesive engagement with the glans.

As indicated, direct tenacious adhesive engagement between the glans andthe sleeve is to be avoided and the embodiments of this invention arecapable of achieving that objective while at the same time protectingthe glans against objectionable liquid contact and securing the catheterin place by adhesive contact elsewhere (behind the coronal ridge).Protection of the proximal surfaces of the glans occurs because thesleeve 12, 12' is stretched about those surfaces, and it is conceivablethat such protection might be enhanced if a suitable sealant havinglittle or no adhesive properties were interposed between the sleeve andthe glans. A water-insoluble jelly, or any of a variety of sealantcompositions commonly used in the ostomy field, and in the medical fieldgenerally, might be employed. In any event, such sealant should make nosubstantial adhesive contact with the glans, it being both a purpose andan advantage of this system to avoid such adhesive contact while at thesame time providing a protective sealing covering over the glans.

While in the foregoing, embodiments of the invention have been disclosedin considerable detail, it will be understood by those skilled in theart that many of these details may be varied without departing from thespirit and scope of the invention.

I claim:
 1. A method of securing an external male catheter upon a wearerto protect surfaces of the glans against injury from direct urinecontact while at the same time avoiding objectionable adhesiveengagement between the catheter and the glans, comprising the steps ofproviding an external catheter having a tubular sheath formed of softelastic material and including a thin-walled cylindrical body section, areduced drainage tube section, a tapered neck section disposed betweensaid body and drainge tube sections, and an inner sleeve of soft elasticdisposed within said sheath and having a proximal end portion mergingand permanently integrated with said cylindrical section and anelongated distal end portion extending and tapering distally into saidneck section; said elongated distal end portion of said sleeveterminating distally in a reduced opening spaced axially from the distalend of said neck section and having an outer surface unsecured andnormally spaced inwardly from said neck section along substantially thefull length and circumferential extent of said distal end portion;fitting said catheter upon a wearer's penis with said cylindricalsection extending along the shaft of the penis behind the glans thereofand with said inner sleve stretched about the glans and in protectivebut substantially non-adhesive engagement therewith; and maintainingsaid inner sleeve in protective substantially non-adhesive engagementwith said glans by adhesively securing said cylindrical body section tothe shaft of the penis behind the corona of the glans.
 2. The method ofc1aim 1 in which said step of adhesively securing said cylindrical bodysection of said sheath to the shaft of the penis comprises first coatingat least a portion of the interior surface of said cylindrical bodysection with a pressure-sensitive adhesive before fitting said catheterupon the wearer.
 3. The method of claim 1 in which said step ofadhesively securing said cylindrical bdy section of said sheath to theshaft of the penis comprises placing an adhesive pad having tackyadhesive inner and outer surfaces about the penile shaft directly behindthe glans prior to the step of fitting said catheter upon the wearer. 4.The method of claim 1 in which said catheter is provided with saidcylindrical body section and the proximal portion of said sleeve inrolled form to expose the distal portion of said sleeve in stretchedcondition within said neck section; said catheter being fitted upon thewearer by first urging the glans into contact with the stretched sleeveof the rolled catheter and with the urethral meatus aligned with thedistal opening of said sleeve, and then unrolling said catheter to coverthe remainder of said glans with said sleeve and to unroll saidcylindrical body section over the penile shaft behind said glans.